Oxygenation by 100% Oxygen Via High Flow Nasal Cannula in Surgical Patients

NCT02706431 | Completed

• 1 other identifier: Apnoic Oxygenation
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a limited number of studies. Although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice. The general purpose of this project is to evaluate a new ventilation strategy during ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on gas exchange.

Conditions

Anaesthesia, General; Anesthesia, Intravenous; Ventilation

Outcome Measures

Primary Outcomes (3)

• Change in arterial carbon dioxide (pCO2)

  From start of anaesthesia to end of apnoea oxygenation or max 30 minutes

• Change in arterial pH

  From start of anaesthesia to end of apnoea oxygenation or max 30 minutes

• Change in arterial oxygen tension (pO2)

  From start of anaesthesia to end of apnoea oxygenation or max 30 minutes

Secondary Outcomes (4)

• Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pCO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?

  In the end of the apnoea period, i.e. at approximately 20 minutes

• Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pH in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?

  In the end of the apnoea period, i.e. at approximately 20 minutes

• Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?

  In the end of the apnoea period, i.e. at approximately 20 minutes

• Does the high oxygen content cause atelectasis measures as change in relation between pCO2 and end tidal carbon dioxide

  Until discharge from the postoperative unit, often max 2 hours

Study Arms (2)

Normoventilation

NO INTERVENTION

The patients will be normoventilated before anesthesia

Hyperventilation

EXPERIMENTAL

Prior to anesthesia, the patients will hyperventilate during 2 mins or until symptoms from the central nervous system (e.g. dizziness).

Procedure: Hyperventilation

Interventions

Hyperventilation PROCEDURE

Hyperventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, \>18 years old
• ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery) and the anesthesia time is \<40 mins.
• Capable of understanding the study information and sign the written consent.

You may not qualify if:

• ASA\>2
• NYHA \>2
• BMI \>30
• Pregnancy
• Manifest cardiac failure or coronary disease
• Neuromuscular disease

Sponsors & Collaborators

• Karolinska University Hospital: lead

Related Publications (1)

• Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.

  PMID: 28403407 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Malin Jonsson Fagerlund, MD, PhD

  Karolinska University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Senior Consultant

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: March 11, 2016
• Study Start: December 1, 2015
• Primary Completion: June 30, 2016
• Study Completion: September 1, 2016
• Last Updated: December 19, 2017

Record last verified: 2017-12